Helena Laboratories, Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Helena Laboratories, Corp. - FDA 510(k) Cleared Devices
Recent clearances: SPIFE A1AT kit, V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
2
Total
2
Cleared
0
Denied
Helena Laboratories, Corp. has 2 FDA 510(k) cleared medical devices. Based in Beaumont, US.
Last cleared in 2022. Active since 2022. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Helena Laboratories, Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Helena Laboratories, Corp.
2 devices